The present invention relates, in general, to an energy based surgical device, and more particularly, to a new and useful ultrasonic surgical device for repairing a defect in tissue such as an inguinal hernia, utilizing a prosthetic and the application of ultrasonic energy.
It is established practice in the surgical field to repair defects in tissue, for instance, an inguinal hernia, through the use of PROLENE(trademark) mesh (manufactured and sold by Ethicon, Inc., Somerville, N.J.). Generally the mesh is cut to a desired size for placement over the inguinal hernia. Once the sized mesh has been placed over the defect, the mesh is attached to the surrounding inguinal tissue using several known attachment means.
Once the mesh is in place, it is important that the mesh serve as a barrier over the defect in order to restrict the lower viscera in the patient""s abdomen from protruding through the defect. Accordingly, it is essential that the attachment means used to secure the mesh to the inguinal tissue have an initial strength of several pounds of force in both the tensile and shear directions. Moreover, it is important that the mesh remain in place for several days so that natural adhesions can form to ensure that the mesh is sufficiently anchored to the tissue.
One common way of attaching the mesh to tissue is through the use of suture and needle. As would be expected, the suturing technique for this procedure requires a great deal of skill and is normally conducted by very experienced surgeons, especially for minimally invasive or laparoscopic procedures. Since the learning curve for laparoscopic suturing is extremely steep, many surgeons are slow to adopt this technique.
In response to the challenges associated with suturing, other fastening techniques have evolved. Accordingly, it is now common practice to use a surgical stapler such as the ENDOSCOPIC MULTI-FIRE STAPLER(trademark), (manufactured and sold by Ethicon Endo-Surgery, Inc., Cincinnati, Ohio). U.S. Pat. No. 5,470,010 (Rothfuss et al.) discloses a disposable, endoscopic stapler that is used to place a number of staples at various locations of the placed mesh in order to properly secure the mesh to the tissue. Although the endoscopic stapler is efficient and easy to use for a surgeon, there is a cost issue associated with its use for this type of procedure.
In an effort to alleviate the costs associated with a disposable, multiple fire stapler, some surgeons prefer a re-usable, xe2x80x9csingle shotxe2x80x9d stapler such as disclosed in U.S. Pat. No. 5,246,156 (Rothfuss et al.). Although there is a cost savings to the user, the procedure time is extended when using this type of stapler over the disposable, multiple fire stapler.
In addition to using surgical staplers to secure mesh to inguinal tissue to repair a hernia, other types of fasteners have been developed. One of these fasteners is a helical fastener such as disclosed in U.S. Pat. No. 5,258,000 (Gianturco). This type of fastener is also disclosed in WO 96/03925 (Bolduc et al.). However, although these types of fasteners are also easy to use and decrease the procedure time, cost is also an issue.
It is important to note that, presently, the known devices or attachment means for repairing tissue defects are mechanical devices such as endoscopic staplers or fasteners or simple needle and suture. Presently, there are no known energy-based delivery devices or energy-based methods that are capable of performing tissue repair such as that described above.
Accordingly, the present invention is a novel energy based surgical device. The surgical device has a housing, and an acoustic assembly for the generation of ultrasonic energy. The acoustic assembly includes a solid core waveguide that extends from the housing and has a novel angled surface end effector at the distal end. The angled surface end effector conducts ultrasonic energy and has a cylindrical shaft. An embedding surface is located at the distal end of the shaft, and an angled coagulating surface extends proximally from the embedding surface. The angled coagulating surface is said angled from the longitudinal axis of the cylindrical shaft and is angled outwardly from the embedding surface.
A second embodiment of the energy based surgical device according to the present invention comprises a housing and an acoustic assembly for the generation of ultrasonic energy. A solid core waveguide is operably coupled to the acoustic assembly and extends from the housing. A novel truncated cone end effector is located at the distal end of the acoustic assembly for the conduction of ultrasonic energy thereto. The truncated cone end effector includes a truncated conical shaft having an embedding surface at the distal end. A circumferential tissue coagulating surface is angled away from the embedding surface.
The present invention is a novel ultrasonic surgical device for emulsifying and coagulating tissue during a surgical procedure. In particular, the present invention is well adapted for repairing a defect in tissue when used with a prosthetic. The ultrasonic surgical device of the present invention is useful for various types of surgical procedures, and is particularly useful for the repair of an inguinal hernia.
Significantly, the ultrasonic surgical device provides the surgeon with an improved method of attaching a prosthetic over a tissue defect. The surgeon makes an initial application of ultrasonic energy to the prosthetic and surrounding tissue to embed the prosthetic with the embedding surface of the end effector, and a second application of ultrasonic energy to weld the prosthetic in place with the coagulation surface of the end effector. Consequently, the surgeon is provided with a time saving method of attaching a prosthetic onto tissue. In particular, if the tissue repair is the attachment of a patch over a tissue defect, such as an inguinal hernia, the timesaving can be significant. A preferred prosthetic of the present invention is a mesh patch.
It is an object of the present invention to provide the surgeon with an energy based surgical device having an end effector with a distal embedding surface of sufficient size to rapidly emulsify a portion of tissue. Additionally, the end effector provides the surgeon with a coagulation surface to rapidly coagulate the previously emulsified tissue in a surgical procedure such as the attachment of a prosthetic to tissue.
As it can be well appreciated, the novel device and method according to the present invention is applicable to many surgical procedures, and more particularly, to a hernia repair surgical procedure for repairing a defect in the tissue of the inguinal anatomy or inguinal hernia.
It is yet another object of the present invention to provide an energy based surgical device having a novel end effector for repairing tissue, such as an inguinal hernia, that is minimally invasive, time and cost effective and easy to use.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of the disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which the preferred embodiments of the invention are illustrated.